NCT03733912

Brief Summary

To investigate the effect of Plasticizer metabolites concentration on the in vitro fertilization outcomes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

2.5 years

First QC Date

November 6, 2018

Last Update Submit

February 17, 2021

Conditions

Fertilization in Vitro

Outcome Measures

Primary Outcomes (1)

  • Phthalate of urine

    Phthalate metabolites concentrations

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Phthalate of environmental dust

    through study completion, an average of 1 year

Study Arms (2)

Pregnancy

Infertile women undergoing in vitro fertilization cycle got pregnancy successfully. The pregnancy persisted over 12 weeks.

Other: Phthalate metabolites measurement

Non-pregnancy

Infertile women undergoing in vitro fertilization cycle failed to reach pregnancy.

Other: Phthalate metabolites measurement

Interventions

Phthalate metabolites measurementOTHER

To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups

Also known as: diethylhexyl phthalate
Non-pregnancyPregnancy

Eligibility Criteria

Age30 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

This study was conducted in a medical center in southern Taiwan. 80 infertile female patients, aged 30 to 40 years old with normal ovarian function, receiving IVF treatment in the infertility outpatient were enrolled in this study. The participates were divided into two groups: successful pregnancy in the IVF cycle (n = 40) and non-pregnancy in the IVF cycle (n = 40). After getting the consent of the patients, we plan to do a questionnaire survey. Additionally, environmental dust and urine were sampled and analyzed the concentration of plasticizers metabolites.

You may qualify if:

  • Infertile women undergoing in vitro fertilization cycles
  • Normal ovarian reserve (AMH \> 1.0 and AFC ≧ 5)

You may not qualify if:

  • Daily homestay time \> 12 hrs
  • Diminished ovarian reserve (AMH ≦ 1.0 or AFC\<5)
  • Oophorectomy
  • Gynecologic cancer patients
  • Severe male infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

Location

Related Publications (13)

  • Messerlian C, Souter I, Gaskins AJ, Williams PL, Ford JB, Chiu YH, Calafat AM, Hauser R; Earth Study Team. Urinary phthalate metabolites and ovarian reserve among women seeking infertility care. Hum Reprod. 2016 Jan;31(1):75-83. doi: 10.1093/humrep/dev292. Epub 2015 Nov 15.

    PMID: 26573529BACKGROUND

  • Chen ML, Chen JS, Tang CL, Mao IF. The internal exposure of Taiwanese to phthalate--an evidence of intensive use of plastic materials. Environ Int. 2008 Jan;34(1):79-85. doi: 10.1016/j.envint.2007.07.004. Epub 2007 Aug 31.

    PMID: 17765308BACKGROUND

  • Jurewicz J, Hanke W. Exposure to phthalates: reproductive outcome and children health. A review of epidemiological studies. Int J Occup Med Environ Health. 2011 Jun;24(2):115-41. doi: 10.2478/s13382-011-0022-2. Epub 2011 May 19.

    PMID: 21594692BACKGROUND

  • Koch HM, Lorber M, Christensen KL, Palmke C, Koslitz S, Bruning T. Identifying sources of phthalate exposure with human biomonitoring: results of a 48h fasting study with urine collection and personal activity patterns. Int J Hyg Environ Health. 2013 Nov;216(6):672-81. doi: 10.1016/j.ijheh.2012.12.002. Epub 2013 Jan 18.

    PMID: 23333758BACKGROUND

  • Shea KM; American Academy of Pediatrics Committee on Environmental Health. Pediatric exposure and potential toxicity of phthalate plasticizers. Pediatrics. 2003 Jun;111(6 Pt 1):1467-74. doi: 10.1542/peds.111.6.1467.

    PMID: 12777573BACKGROUND

  • Becker K, Seiwert M, Angerer J, Heger W, Koch HM, Nagorka R, Rosskamp E, Schluter C, Seifert B, Ullrich D. DEHP metabolites in urine of children and DEHP in house dust. Int J Hyg Environ Health. 2004 Oct;207(5):409-17. doi: 10.1078/1438-4639-00309.

    PMID: 15575555BACKGROUND

  • Du YY, Guo N, Wang YX, Hua X, Deng TR, Teng XM, Yao YC, Li YF. Urinary phthalate metabolites in relation to serum anti-Mullerian hormone and inhibin B levels among women from a fertility center: a retrospective analysis. Reprod Health. 2018 Feb 23;15(1):33. doi: 10.1186/s12978-018-0469-8.

    PMID: 29471860BACKGROUND

  • Wu H, Ashcraft L, Whitcomb BW, Rahil T, Tougias E, Sites CK, Pilsner JR. Parental contributions to early embryo development: influences of urinary phthalate and phthalate alternatives among couples undergoing IVF treatment. Hum Reprod. 2017 Jan;32(1):65-75. doi: 10.1093/humrep/dew301. Epub 2016 Dec 7.

    PMID: 27927842BACKGROUND

  • Vabre P, Gatimel N, Moreau J, Gayrard V, Picard-Hagen N, Parinaud J, Leandri RD. Environmental pollutants, a possible etiology for premature ovarian insufficiency: a narrative review of animal and human data. Environ Health. 2017 Apr 7;16(1):37. doi: 10.1186/s12940-017-0242-4.

    PMID: 28388912BACKGROUND

  • Minguez-Alarcon L, Gaskins AJ. Female exposure to endocrine disrupting chemicals and fecundity: a review. Curr Opin Obstet Gynecol. 2017 Aug;29(4):202-211. doi: 10.1097/GCO.0000000000000373.

    PMID: 28557831BACKGROUND

  • Richardson MC, Guo M, Fauser BC, Macklon NS. Environmental and developmental origins of ovarian reserve. Hum Reprod Update. 2014 May-Jun;20(3):353-69. doi: 10.1093/humupd/dmt057. Epub 2013 Nov 27.

    PMID: 24287894BACKGROUND

  • Hauser R, Gaskins AJ, Souter I, Smith KW, Dodge LE, Ehrlich S, Meeker JD, Calafat AM, Williams PL; EARTH Study Team. Urinary Phthalate Metabolite Concentrations and Reproductive Outcomes among Women Undergoing in Vitro Fertilization: Results from the EARTH Study. Environ Health Perspect. 2016 Jun;124(6):831-9. doi: 10.1289/ehp.1509760. Epub 2015 Nov 6.

    PMID: 26545148RESULT

  • Wu H, Olmsted A, Cantonwine DE, Shahsavari S, Rahil T, Sites C, Pilsner JR. Urinary phthalate and phthalate alternative metabolites and isoprostane among couples undergoing fertility treatment. Environ Res. 2017 Feb;153:1-7. doi: 10.1016/j.envres.2016.11.003. Epub 2016 Nov 19.

    PMID: 27875712RESULT

MeSH Terms

Interventions

Diethylhexyl Phthalate

Intervention Hierarchy (Ancestors)

Phthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Kuan-Hao Tsui, PhD

    Kaohsiung Veterans General Hospital.

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 6, 2018

First Posted

November 7, 2018

Study Start

July 11, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)